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Self-management training: a controlled investigation of its effectiveness in improving coping skills, mood and quality of life with patients with acquired physical disability

Condition category

Mental and Behavioural Disorders

Date applied

10/02/2015

Date assigned

19/02/2015

Last edited

20/02/2015

Prospective/Retrospective

Retrospectively registered

Overall trial status

Completed

Recruitment status

No longer recruiting

Plain English Summary

Background and study aims People with acquired physical impairments, such as limb amputation and spinal cord injury,commonly experience additional problems including pain, anxiety and depression. These problems can prevent them from participating fully in society and can diminish their quality of life (QoL). Traditionally, attempts to improve well-being for people with physical impairments have focused on treatment of these problems after they have become established. Opportunities for early intervention to manage pain and other problems before they become chronic are typically missed. Self-management (SM) interventions have been developed in the context of patient-centred care, where patients are empowered to take a central role their health and well-being. SM interventions aim to provide patients with the necessary skills and confidence to deal with health-related problems and to manage negative emotions. SM has been used widely in chronic illnesses in which pain and disability are common. However, SM has not been used as a preventive intervention during the early rehabilitation phase following physical impairment. The aim of our research is to investigate how well an SM programme works for the prevention of disabling secondary conditions and improvement of QoL following the onset of significant physical impairment. The key objective is to improve health and wellbeing. As the impact of acquired physical impairment extends beyond the individual patient to families and friends, improving health and quality of life for the patient will have positive spill over effects for families, friends and wider communities.

Who can participate? Adults with limb amputation or spinal cord injury.

What does the study involve?Participants are randomly allocated to one of two groups: receiving usual care plus the “Next Steps UK and Ireland self-management programme” or receiving usual care only.

What are the possible benefits and risks of participating? Not provided at time of registration

Where is the study run from?National Rehabilitation Hospital, Ireland

When is the study starting and how long is it expected to run for? From February 2011 to July 2014.

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Study information

Scientific title

Promoting quality of life and preventing secondary disability following acquired physical impairment: a controlled trial of a self-management intervention

Acronym

Study hypothesis

1. Compared to standard treatment alone, individuals who receive the self-management intervention plus standard care will have lower levels of depressive and anxiety symptoms, and improved positive affect and positive mindset. 2. Compared to standard treatment alone, individuals who receive the self-management intervention will have higher levels of participation and health related quality of life. 3. Changes in both primary and secondary outcomes will correlate strongly with the intermediate outcome of self-efficacy.

Patient information sheet

Condition

Intervention

Participants were allocated to control or intervention groups according to timing of admission. Control group participants received usual care. Participants in the intervention group received usual care plus the 'Next Steps UK & Ireland self-management programme'.

Overall trial start date

01/02/2011

Overall trial end date

01/12/2015

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

Inclusion criteria consist of (1) being aged 18 years or older; (2) having limb amputation or spinal cord injury; (3) English speaking; (4) no more than 3 weeks previous inpatient rehabilitation for the current condition; onset of index injury/condition within 1 year.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

160

Participant exclusion criteria

Exclusion criteria: unable to provide informed consent; severe cognitive impairment; presence of any other serious health condition that attending physician believes limits their ability to participate in the study.